Stool Softener

Drug Facts

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitol Sorbitan

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2018-03-29

Medication Information

Purpose

Stool softener laxative

Description

Drug Facts

Uses

for relief of occasional constipation (irregularity)
this product generally produces a bowel movement in 12 to 72 hours

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50568-5

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use

Directions

take softgels with a full glass (8oz) of water

adults and children 12 years and older	take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses.
children 6 to under 12 years	take 1 softgel daily or as directed by a doctor
children under 6 years	ask a doctor

Other Information

each softgel contains: sodium 5 mg
store at room temperature 15°-30°C (59°-86°F)
protect from excessive humidity

Inactive Ingredients

anhydrous citric acid, FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink

Questions Or Comments?

Call toll free: 1-855-215-8180

Principal Display Panel

Stool Softener

DOCUSATE SODIUM 100 mg 30 SOFTGELS

Compare to Phillips' Stool Softener Liquid Gels active ingredient

NDC 51013-433-20

Stop Use and Ask A Doctor If

you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
you need to use a laxative for more than 1 week

Active Ingredient (in Each Softgel)

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have

stomach pain, nausea, or vomiting
a sudden change in bowel habits that lasts over 14 days

Structured Label Content

Uses

for relief of occasional constipation (irregularity)
this product generally produces a bowel movement in 12 to 72 hours

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use

Purpose

Stool softener laxative

Directions

take softgels with a full glass (8oz) of water

adults and children 12 years and older	take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses.
children 6 to under 12 years	take 1 softgel daily or as directed by a doctor
children under 6 years	ask a doctor

Other Information (Other information)

each softgel contains: sodium 5 mg
store at room temperature 15°-30°C (59°-86°F)
protect from excessive humidity

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink

Questions Or Comments? (Questions or comments?)

Call toll free: 1-855-215-8180

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Stool Softener

DOCUSATE SODIUM 100 mg 30 SOFTGELS

Compare to Phillips' Stool Softener Liquid Gels active ingredient

NDC 51013-433-20

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
you need to use a laxative for more than 1 week

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

stomach pain, nausea, or vomiting
a sudden change in bowel habits that lasts over 14 days

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information